Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission

Hypoglycemia Clinical Trial

Official title:

A Retrospective Analysis of the Effects of a Hypoglycemia Protocol With Glucose Gel on NICU Admission

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04085978
• Other study ID #: 501938027
• Status: Terminated
• Start date: May 4, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: October 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Weeks and older

Eligibility

Inclusion Criteria:

• All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

Exclusion Criteria:

• Neonates <34 weeks gestational age or with birth weight less than 2000 grams.

• Infants with serious congenital malformation

• Infants with a terminal disorder.

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety	Banner University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean NICU length of stay rounded to the day	Mean NICU length of stay rounded to the day	30 days
Primary	Mean maximum glucose infusion rate	Mean maximum glucose infusion rate	30 days
Secondary	Assess for complications	- Number of neonates identified to have any type of infection	30 days
Secondary	Assess for weight loss	- Maximum weight loss as percent below birth weight during NICU admission	30 days
Secondary	Evaluate for persistent symptomatic or asymptomatic hypoglycemia	Number of neonates with symptomatic hypoglycemia; Number of neonates with asymptomatic hypoglycemia	30 days
Secondary	Number of neonates who received formula	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days
Secondary	Number of neonates with any breastfeeding during hospitalization	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days
Secondary	Number of neonates with breastfeeding at time of discharge	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days